Scientist, Analytical Development

We're looking for a Scientist, Analytical Development to join our technical operations team. In this role, you'll be instrumental in developing, optimizing, and qualifying analytical methods that support our cutting-edge bioprinted tissue therapeutics. Reporting to our Head, Quality Control and Analytical Development, you'll play a crucial part in ensuring the quality and characterization of our innovative products as we advance toward clinical development. Responsibilities Design, execute, and optimize a variety of analytical methods (e.g. cell-based assays, bioanalytical and flow cytometry methods) for the characterization, release, and stability testing of raw materials, in-process samples, and final drug products. Participate in and execute experiments for the qualification and validation of analytical methods in accordance with phase-appropriate regulatory guidelines (e.g., ICH, FDA, Health Canada, EMA). Perform routine analytical testing as needed to support process development, product characterization, and early-stage stability studies. Accurately record, analyze, interpret, and present experimental data. Author and review technical reports, study protocols, and standard operating procedures (SOPs) in compliance with GxP principles. Identify and troubleshoot analytical method issues, propose solutions, and implement corrective actions. Work cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges. Perform routine maintenance and calibration of analytical instruments and ensure proper functioning. Adhere to and contribute to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations. Qualifications & Experience Education & Experience: Bachelor's or Master's degree in a relevant scientific discipline with 3-5 years of relevant experience in analytical development within the biotechnology or pharmaceutical industry with hands-on experience in cell therapy, gene therapy, or combination products. Analytical Expertise: Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays. GxP Knowledge: Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies. Problem-Solver: You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges. Innovation Mindset: You're eager to learn new techniques and contribute to the continuous improvement of analytical processes. The hiring range for this role is $90,000 - $96,300, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including,…